MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM MULTIAXIAL CROSSLINK 43MM 54MM; IMPLANT-ROD CONNECTOR

Catalog Number 48236043

Device Problem Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2013

Event Type  malfunction  

Event Description

It was reported that during xia 3 surgery, the nut of the crosslink could not be turn.The surgeon used other crosslink and completed the surgery.

Event Description

It was reported that during xia 3 surgery, the nut of the crosslink could not be turn.The surgeon used other crosslink and completed the surgery.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: the xia 3 titanium multiaxial crosslink was confirmed to have a jammed set screw and locknut via functional and visual inspection.The hex bores on the set screws were damaged which is can be caused by excessive tightening force.Excessive torsional forces on the set screws would cause them to deform and become unable to back out of the threads.Conclusion: the most likely cause of this event was due to an excessive force applied while tightening the set screws.

• Brand Name: XIA 3 TITANIUM MULTIAXIAL CROSSLINK 43MM 54MM
• Type of Device: IMPLANT-ROD CONNECTOR
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer Contact: daniel roberts ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 3550601
• MDR Text Key: 3981839
• Report Number: 0009617544-2014-00006
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48236043
• Device Lot Number: 13C501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2013
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR